PMID- 34049983 OWN - NLM STAT- MEDLINE DCOM- 20220301 LR - 20220301 IS - 1535-5667 (Electronic) IS - 0161-5505 (Print) IS - 0161-5505 (Linking) VI - 63 IP - 2 DP - 2022 Feb TI - Efficacy and Safety of (177)Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study. PG - 218-225 LID - 10.2967/jnumed.120.260760 [doi] AB - The purpose of this study was to assess the efficacy and safety of (177)Lu-DOTATATE in patients with somatostatin receptor (SSR)-positive lung neuroendocrine tumors (NETs). Methods: This is a retrospective review of the outcome of patients with typical carcinoid (TC) and atypical carcinoid (AC), treated with (177)Lu-DOTATATE at 2 ENETS Centers of Excellence. Morphologic imaging (RECIST 1.1) and (68)Ga-DOTATATE PET/CT responses were assessed at 3 mo after completion of (177)Lu-DOTATATE. Concordance between 2 response assessment methods was evaluated by kappa statistics. Progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan-Meier analysis and compared by Log-rank test. Treatment-related adverse events (AEs) were graded based on Common Terminology Criteria for Adverse Events, version 5. Results: Of 48 patients (median age, 63 y; 13 women), 43 (90%) had AC and 5 (10%) TC. Almost all patients (47, 98%) were treated due to progression. Most patients (40, 83%) received somatostatin analogs, and 10 patients (20%) had prior everolimus, chemotherapy, or both. All patients had high SSR expression (>/= modified Krenning score 3) on pretreatment (68)Ga-DOTATATE PET/CT. Patients received a median 4 (range, 1-4) cycles of (177)Lu-DOTATATE (33% with concurrent radiosensitizing chemotherapy) to a median cumulative activity of 27 GBq (range, 6-43GBq). At a median follow-up of 42 mo, the median PFS and OS were 23 mo (95% CI, 18-28 mo) and 59 mo (95% CI, 50-not reached [NR]), respectively. Of 40 patients with RECIST-measurable disease and 39 patients with available (68)Ga-DOTATATE PET/CT, response categories were partial response, 20% (95% CI, 10%-35%) and 44% (95% CI, 30%-59%); stable disease, 68% (95% CI, 52%-80%) and 44% (95% CI, 30%-59%); and progressive disease, 12% (95% CI, 5%-27%) by both, respectively. There was a moderate concordance between response categories by RECIST and (68)Ga-DOTATATE PET/CT, weighted kappa of 0.51 (95% CI, 0.21-0.68). Of patients with stable disease by RECIST, those with partial response on (68)Ga-DOTATATE PET/CT had a longer OS than those with no response, NR versus 52 mo (95% CI, 28-64), hazard ratio 0.2 (95% CI, 0.1-0.6), P < 0.001. Most grade 3/4 AEs were reversible and the most common was lymphopenia (14%) with no incidence of myelodysplasia or leukemia. Conclusion: In patients with advanced progressive lung NET and satisfactory SSR expression, (177)Lu-DOTATATE is effective and safe with a high disease control rate and encouraging PFS and OS. CI - (c) 2022 by the Society of Nuclear Medicine and Molecular Imaging. FAU - Zidan, Lamiaa AU - Zidan L AD - Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. FAU - Iravani, Amir AU - Iravani A AD - Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Amir.iravani@wustl.edu. AD - Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia. AD - Washington University School of Medicine, Mallinckrodt Institute of Radiology, St. Louis, Missouri. FAU - Oleinikov, Kira AU - Oleinikov K AD - Neuroendocrine Tumor Unit, ENETS Center of Excellence, Department of Endocrinology and Metabolism, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Ben-Haim, Simona AU - Ben-Haim S AD - Department of Nuclear Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. AD - Institute of Nuclear Medicine, University College London and UCL Hospitals NHS Trust, London United Kingdom. FAU - Gross, David J AU - Gross DJ AD - Neuroendocrine Tumor Unit, ENETS Center of Excellence, Department of Endocrinology and Metabolism, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Meirovitz, Amichay AU - Meirovitz A AD - Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; and. FAU - Maimon, Ophra AU - Maimon O AD - Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; and. FAU - Akhurst, Tim AU - Akhurst T AD - Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. AD - Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia. FAU - Michael, Michael AU - Michael M AD - Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia. AD - Division of Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. FAU - Hicks, Rodney J AU - Hicks RJ AD - Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. AD - Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia. FAU - Grozinsky-Glasberg, Simona AU - Grozinsky-Glasberg S AD - Neuroendocrine Tumor Unit, ENETS Center of Excellence, Department of Endocrinology and Metabolism, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Kong, Grace AU - Kong G AD - Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. AD - Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20210528 PL - United States TA - J Nucl Med JT - Journal of nuclear medicine : official publication, Society of Nuclear Medicine JID - 0217410 RN - 0 (Ga(III)-DOTATOC) RN - 0 (Organometallic Compounds) RN - 0 (Radiopharmaceuticals) RN - AE221IM3BB (lutetium Lu 177 dotatate) RN - RWM8CCW8GP (Octreotide) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Female MH - Humans MH - Lung Neoplasms/diagnostic imaging/mortality/*radiotherapy MH - Male MH - Middle Aged MH - Neuroendocrine Tumors/diagnostic imaging/mortality/*radiotherapy MH - Octreotide/adverse effects/*analogs & derivatives/therapeutic use MH - Organometallic Compounds/adverse effects/*therapeutic use MH - Positron Emission Tomography Computed Tomography MH - Radiopharmaceuticals/*therapeutic use MH - Retrospective Studies PMC - PMC8805789 OTO - NOTNLM OT - bronchial carcinoid OT - lung neuroendocrine tumor OT - peptide receptor radionuclide therapy OT - somatostatin receptor EDAT- 2021/05/30 06:00 MHDA- 2022/03/03 06:00 PMCR- 2022/02/01 CRDT- 2021/05/29 05:41 PHST- 2020/11/21 00:00 [received] PHST- 2021/04/21 00:00 [revised] PHST- 2021/05/30 06:00 [pubmed] PHST- 2022/03/03 06:00 [medline] PHST- 2021/05/29 05:41 [entrez] PHST- 2022/02/01 00:00 [pmc-release] AID - jnumed.120.260760 [pii] AID - 260760 [pii] AID - 10.2967/jnumed.120.260760 [doi] PST - ppublish SO - J Nucl Med. 2022 Feb;63(2):218-225. doi: 10.2967/jnumed.120.260760. Epub 2021 May 28.